Location: Plymouth, MN
Duration: 6+ months
- Responsible for developing and maintaining label content for new and existing medical device products.
- Creates & modifies product labeling, packaging artwork and other related materials incorporating regulatory requirements and branding guidelines.
- Works with external customers to manage labeling developed for or at external suppliers.
- Collaborates with cross functional teams (including Engineering, Marketing, Clinical, Design Assurance, Legal, and Regulatory) to ensure compliance to world -wide regulations, company policies & operating procedures.
- Coordinates production implementation by managing changes within the Quality Management System
- Collects & maintains Unique Device Identification (UDI) information within GUDID database.
- Maintains knowledge of new developments in packaging and labeling technologies.
- Advises functional teams on labeling and UDI impacts regarding manufacturing changes, technology upgrades or new regulations.
- Maintains positive and cooperative communication with all levels of employees, internal & external customers.
- Partners with IT to support Operations by troubleshooting production issues. Supports technology upgrades by executing software or hardware validation.
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
- Performs other related duties and responsibilities, on occasion, as assigned.
- BA or BS degree (degree in a technical discipline highly preferred).
- Professional experience in the medical device industry and/or experience working with a broader enterprise/cross-division business.
- Knowledge of FDA & EU regulations, GMP, GS1 and ISO standards.
- Experience working with design software such as, CAD, Adobe Illustrator/Photoshop.
- Familiarity with enterprise PDM & ERP systems
- Advanced skills with Excel, Access, or database management software
- Ability to work in a highly matrixed and geographically diverse business environment.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
- Ability to identify and solve problems and work independently with little oversight
- Requires ability to be innovative, resourceful, and work with minimal direction
- Ability to schedule and organize multiple projects
- Ability to communicate effectively with internal and external customers and team members.